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75% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p < 0.0001) 100% of patients who achieved 12 month event free survival achieved 2 year overall survival

Company on track to begin submission of a rolling Biologics Licensing Application (BLA) request for OST-HER2 to U.S. Food & Drug Administration in September 2025

66.6% of OST-HER2 treated patients achieved 2-year overall survival compared with 40% in the historical control group (p = 0.0046) FDA issues Biologics Licensing Application (BLA) number for OST-HER2 in preparation for anticipated BLA filing for the prevention or delay of recurrent, fully resected, pulmonary metastatic osteosarcoma following August 27, 2025 End of Phase 2 Meeting Company responds to FDA correspondences seeking to align approval metrics for Regenerative Medicine Advanced Therapy (RMAT) designation, Breakthrough Therapy designation (BTD) and Biologics Licensing Application via Accelerated Approval Program Company’s NYSE American listing included in the Russell Microcap, Russell Microcap Value and Russell Microcap Growth indexes

In this bonus episode, BioSpace’s Vice President of Marketing ⁠Chantal Dresner⁠ and Careers Editor ⁠Angela Gabriel⁠ take a look at Q2 job market performance, layoffs and wider employment trends and policies impacting the biopharma workforce.

Final FDA Type C Meeting December 11, 2025 - biomarker data to be available October 10, 2025 FDA/Osteosarcoma Institute Workshop narrows focus for OST-HER2 overall survival, biomarker correlation & canine osteosarcoma data